General provisions
Article 1 this regulation lays down requirements for the equipment
for use outdoors listed in articles 3 and 4 and
placed on the market in the European economic
area or put into service there as a complete unit
suitable for the intended use.
This regulation does not apply to
1. ancillary equipment that are not motorized and placed
on the market or put into service separately, with the exception of
hand-held concrete-breakers and picks, hammers,
2. equipment intended primarily for the carriage of goods or
passengers by road or by rail, by air or sea,
3. equipment specially designed and constructed for
military or police purposes or for emergency services.
paragraph 2 of this regulation,
the noise directive: European Parliament and Council directive
2000/14/EC of 8 May 2000 on the approximation of the laws of the
Member States relating to the noise emission in the environment by
equipment for use outdoors, as last amended
by European Parliament and Council Regulation (EC)
No 219/2009,
equipment: all equipment as defined in
Article 2 (a), (b) and (c) of the European Parliament and Council directive
2006/42/EC of 17 May 2006 on machinery, and amending
Directive 95/16/EC (recast), as last amended by
European Parliament and Council Regulation (EC) no 596/2009,
is either self-propelled or can be moved and which, irrespective
the propulsion system is designed in accordance with its type
be used outdoors and which contributes to noise exposure in
the environment,
the use of outdoor equipment: the use of equipment in a
environment where sound is not or only to a limited extent be prevented from
spread, for example. in tents, under roofs for protection against rain or in empty
houses,
labels: to provide equipment with visible, legible and
indelible mark as defined in Council decision
93/465/EEC of 22 July 1993 concerning the modules for the various phases of the
various phases of the conformity assessment procedures and the rules for the
the affixing and use of the CE conformity marking
intended to be used in the technical harmonisation directives, accompanied
by the indication of the guaranteed sound power level,
sound power level Lwa: A-weighted sound power level in dB in relation
to 1 pW as defined in EN ISO 3744:1995 and
EN ISO 3746:1995;
measured sound power level "means a sound power level as determined
According to the measurements set out in annex III to
the noise directive; the measured values can be determined either
for a single machine that is representative of the type of equipment
or as the mean value of a number of machines,
guaranteed sound power level "means a sound power level as determined
in accordance with the requirements of annex III to the noise directive, including the
uncertainties due to production variation and
measurement procedures and where the manufacturer, or
the manufacturer's authorised representative established within the European Union confirms that the
According to the technical instruments applied and referred
to in the technical documentation are not exceeded,
The EU declaration: such a declaration referred to in
the noise directive.
The definitions of the various types of equipment listed in
This regulation is contained in annex I to the noise directive.
Regulation (2011:126).
Requirements for noise emissions
section 3 of the guaranteed sound power level of such equipment as
specified in annex 1 which are placed on the market or put into service
must not exceed the sound power levels as set out in the annex.
This equipment shall also be marked with the guaranteed
the sound power level.
section 4 of the Marking of the guaranteed sound power level shall be made on
the equipment specified in annex 2.
Requirements for the placing on the market
paragraph 5 of the Equipment shall not be placed on the market or
in service until the manufacturer, or the manufacturer's agent
ensures that the
1. the equipment complies with the requirements of this regulation,
2. the conformity assessment procedures
referred to in paragraph 6 has been completed, and
3. the equipment bears the CE marking and the indication of the
guaranteed sound power level and is accompanied by an EU Declaration
of conformity.
If neither the manufacturer or manufacturer's representative is
established in the European Union, the obligations under
This regulation is fulfilled by the placing
the equipment on the market or putting it into service in the
Union area.
Despite the fact that the equipment does not meet the requirements of this
Regulation, the equipment will be shown at fairs,
exhibitions, demonstrations or other equivalent
occasions. The equipment must be a clearly visible
marking where it clearly states that the equipment does not
meets the requirements and that it will not be placed on the
the market or put into service. Regulation (2010:1334).
Assessment of conformity
section 6 Before the equipment referred to in paragraph 3 are placed on the
the market or put into service, the manufacturer or his authorised
agents let every kind of equipment shall be subjected to one of the following
conformity assessment procedures:
1. internal control of production with assessment of technical
documentation and periodical checking according to annex 3,
or
2. unit verification according to annex 4, or
3. full quality assurance according to annex 5.
Before the equipment referred to in paragraph 4 is placed on the market
or put into service within the community, the manufacturer or his
established agents let each type of equipment shall be subjected to the
procedure of internal production control as set out
Annex 6.
Declaration of conformity with the applicable requirements
section 7 of the manufacturer of the equipment or the manufacturer's agent
shall, for each type of equipment to establish an EU Declaration
of conformity. Declaration of conformity,
established in Swedish, if equipment is placed in service in
Sweden. Such a declaration shall contain
1. name and address of the manufacturer or the manufacturer's
authorised representative established within the European Union,
2. name and address of the person who holds the technical
documentation,
3. Description of the equipment,
4. the procedure for conformity assessment
have been complied with and, where appropriate, the relevant notified
the Agency's name and address,
5. the measured sound power level on an equipment
representative of this type,
6. guaranteed sound power level for this equipment,
7. a reference to the noise directive,
8. a declaration that the equipment conforms to
the requirements of the noise directive,
9. where applicable, a declaration of conformity and
a reference to other Community directives applied,
10. place and date of the Declaration, and
11. information about the person who is authorised to
sign the legally binding declaration for the
the manufacturer or the manufacturer's established within the Union
agents.
The manufacturer of the equipment or the authorised within the
representative established within the European Union, for 10 years from the
date on which the equipment was last manufactured preserve a
copies of the Declaration, together with the technical
the documentation referred to in annex III, point 3, annex 4
point 2, annex 5, paragraphs 3.1 and 3.3 and annex 6
point 3. Regulation (2010:1334).
Labelling requirements
paragraph 8 of the Equipment placed on the market or put into service, and
consistent with the requirements of this Regulation shall be
bears the CE conformity marking. Concerning The CE
tagging and how it should be designed in relation to the European Parliament and of the
Council Regulation (EC) no 765/2008 of 9 July 2008 setting out the requirements
for accreditation and market surveillance relating to the marketing
of products and repealing Regulation (EEC) No 339/93 and
Act (2011:791) on accreditation and technical control.
Marking shall be accompanied by the indication of the guaranteed
sound power level as set out in annex IV to
the noise directive. The indication of the guaranteed sound power level
shall be affixed in a visible, legible and indelible form on the
each device.
If the equipment referred to in paragraphs 3 and 4 are subject to other directives
in terms of other factors which also concerns the CE marking, the latter shall of
the labelling shall indicate that the equipment is also consistent with
the requirements of those other directives. If one or more of the other
directives allows the manufacturer, during a transitional period
choose what rules he must follow, the CE marking set
that the equipment only fulfils the requirements of the directive
the manufacturer has followed. In this case, the reference to these
legal acts is provided in the documents, notices or instructions
supplied with the equipment. Regulation (2011:822).
Supervision
§ 9 Transport Board shall exercise supervision over the Central
compliance with this regulation and regulations
issued pursuant to the regulation. The municipal
Councils fulfill tasks in environmental and
health protection zone shall exercise the local supervision in each
municipality.
Regulatory authorities shall cooperate whenever necessary in
supervisory work. Regulation (2008:1198).
Notified bodies
section 10 of the regulations on appearance and notification of bodies
perform the tasks in relation to conformity assessment
see Act (2011:791) on accreditation and technical control.
Regulation (2011:822).
Appropriations
section 11 of the Transport Board may announce the additional
regulations required that equipment must meet the
requirements of this regulation.
Authorisation to provide for fees, see
Ordinance (1998:1709) if exhaust requirements for certain
internal combustion engine driven mobile machines.
Regulation (2010:1601).
The collection of noise data
section 12 of the equipment manufacturer or manufacturer's within
Union authorised representative shall send a copy of the EU
Declaration of conformity to the European Commission
and Transport Board for each type of equipment, if the
is made in Sweden or to be placed in service in Sweden as
the first country in the European economic area.
Regulation (2010:1334).
Responsibility and appeals
paragraph 13 of the rules relating to liability for infringement under the
This regulation or regulations adopted pursuant
Regulation and about the appeal of an administrative authority
decisions in individual cases can be found in the law (1998:1707) on measures
against noise and exhaust emissions from non-road mobile machinery.
Annex 1 is not included here. The annex as last amended by
Regulation (2006:151).
Annex 2
Equipment subject to noise marking only
(Definitions of the equipment specified in annex I to
the noise directive)
1. aerial access platforms with combustion engines
2. brush cutters
3. construction hoists for the transport of goods (with electric motor)
4. band-saws for construction sites
5. circular saws for construction sites
6. portable chainsaws
7. combined high pressure flushers and suction vehicles
8. compaction machines (only explosion rammers with diesel engine)
9. concrete or mortar mixers
10. construction winches (with electric motor)
11. conveying and spraying machines for concrete and
mortar
12. belt conveyors
13. cooling equipment on vehicles
14. drill rigs
15. equipment for loading and unloading tanks or silos on
trucks
16. glass recycling containers
17. lawn trimmers and lawn edge trimmers
18. hedge trimmers
19. high pressure washer
20. high pressure water jet machines
21. Hydraulic hammers
22. Joint cutting machines
23. leaf blower
24. leaf collector
25. counterbalanced lift trucks with internal combustion engines
26. mobile waste containers
27. paver-finishers (with highly compressed puller)
28. piling equipment
29. it specialist
30. groomers
31. power generators (> = 400 kW)
32. power sweepers
33. refuse collection vehicle
34. milling machines
35. the Ripper
36. chippers
37. snow removing machines with rotating tools (self-propelled, excluding
ancillary equipment)
38. slamsugningsfordon
39. trenchers
40. rotertransportbilar
41. water pump units (not submersible).
Annex 3
Internal control of production with assessment of technical
documentation and periodical checking
1. this annex describes the procedure to be followed
by the manufacturer or the manufacturer's in the Union
authorised representative who fulfils the obligations laid down in paragraphs 2,
5 and 6 to ensure and certify that the relevant
the equipment complies with the requirements of this regulation.
The manufacturer or his representative shall according to section 8 of this regulation
on all equipment affix the CE marking on the
conformity and the indication of the guaranteed
the sound power level and draw up a written declaration of
compliance in accordance with article 7 of this regulation.
2. the manufacturer or his representative shall draw up the technical
documentation described in section 3 and for at least 10 years
After the last product
manufacturing date keep this available for interested
national authorities for inspection purposes. Manufacturer
or the Registrar may assign the responsibility to preserve the
technical documentation to another person. In this case,
manufacturer or agent must include the person's name
and address in their EU-Declaration of conformity.
3. The technical documentation shall enable a
assessment of whether the equipment complies with the
the requirements of this regulation. It should contain at least
the following information:
– the name and address of the manufacturer or the manufacturer's within
representative established within the European Union,
– a description of the equipment,
-the make,
-trade names,
– type, serial and serial number,
– the technical data relevant for the identification of
the equipment and the assessment of the noise the
accomplishes, including, where appropriate, schematic
drawings and descriptions and explanations
is necessary to understand these,
– a reference to the noise directive,
– the technical report of noise measurements carried out
in accordance with the provisions of this regulation, and
-the technical instruments applied and the results of
the evaluation of the uncertainties due
variation in the manufacturing process and their connection with the
guaranteed sound power level.
4. The manufacturer shall take all measures necessary for
the manufacturing process shall ensure that the
manufactured equipment with the technical
the documentation referred to in paragraphs 2 and 3, in
the requirements of this regulation.
5. evaluation by the notified body before the product
placed on the market
The manufacturer or his representative shall present a copy of the
technical documentation to a notified body of his
before the first piece of equipment placed on the
the market or put into service.
If there is doubt about the technical documentation
reliability, the notified body shall inform the
the manufacturer or the representative thereof and, if necessary, carry
or have carried out modifications to the technical
documentation, or possibly, tests deemed
necessary.
Since the notified body has issued a report that
confirming that the technical documentation satisfies
the provisions of this regulation, the manufacturer or
officers in accordance with section 8 of this Regulation shall affix the CE
the marking on the equipment and on its own responsibility to issue a
EU Declaration of conformity.
6. evaluation by the notified body during
manufacture
The manufacturer or his representative shall also allow the notified
body involved in the production phase in accordance with
one of the following procedures (a or b) that the manufacturer
or representative may choose:
(a)) the notified body shall carry out periodic checks
to ensure that the manufactured equipment
continue to comply with the technical
documentation and with the requirements of this regulation; the
notified body shall focus in particular on:
-the correct and complete marking of the equipment according to
section 8 of this regulation,
– the issue of the EU Declaration of conformity in accordance with article 7 of
This regulation,
-the technical instruments applied and the results of
the evaluation of the uncertainties due
variations in production and their connection with the
guaranteed sound effect.
The manufacturer or his representative shall give the notified body
free access to all the internal documentation supporting
These procedures, the actual results of the internal
the audits and possible corrective actions as
been taken.
Only if the above checks give a
unsatisfactory results shall the notified body
carry out noise tests, which, in accordance with its own
judgement and experience can be simplified or carried out fully
out in accordance with the provisions of annex III to the directive of noise
for the type of equipment involved.
(b)) the notified body shall carry out or have carried out
product checks at random intervals. A
appropriate number of sample units of finished product, selected
by the notified body, must be examined and appropriate
noise tests in accordance with annex III of the noise directive
or equivalent tests, shall be carried out in order to verify that
the product is in conformity with the corresponding provisions of the
This regulation. Product verification shall include
the following:
-the correct and complete marking of the equipment according to
section 8 of this regulation,
– the issue of the EU Declaration of conformity in accordance with article 7 of
This regulation.
Under both procedures, the frequency of
be determined by the notified body in accordance with
the results of previous evaluations, the need for
to monitor corrective actions and the additional
guidelines for the frequency of the checks that may follow from the
annual production and manufacturer's General
reliability in terms of maintaining the guaranteed
the values. A control should be performed at least every
third year.
If there is doubt regarding the technical
plausibility or compliance
during production, the notified body shall inform the
the manufacturer or the representative thereof.
In the case of the controlled equipment is not
comply with the provisions of the noise directive, the
the notified body must inform the notifying Member State.
Regulation (2010:1334).
Annex 4
Unit verification
1. this annex describes the procedure which the manufacturer
or the manufacturer's authorised representative established within the European Union,
follow to ensure and insure that the equipment
provided with the certificate referred to in paragraph 4 fulfil the
the requirements of this regulation. The manufacturer or his representative shall
affix the CE marking on the equipment is accompanied by
the information referred to in section 8 of this regulation, and shall draw up a
written declaration of conformity in accordance with article 7 of
This regulation.
2. the manufacturer or his representative shall submit an application for
unit verification with the notified
bodies.
The application shall contain the following information:
– the name and address of the manufacturer and, if the application is submitted
of the manufacturer's representative, his name and address,
– a written declaration that the same application has not been
lodged with any other notified body,
– a technical documentation in accordance with the following
requirements:
a) description of the equipment,
b) trade names,
c) type, series and serial number,
(d)) the technical data relevant for the identification
of the equipment and the assessment of the noise the
accomplishes, including, where appropriate, schematic
drawings and descriptions and explanations
is necessary to understand these, and
e) a reference to the noise directive.
3. The notified body shall:
-examine whether the equipment has been manufactured according to the
technical documentation,
– agree with the applicant as to where the noise tests will be
be carried out, in accordance with this regulation,
– in accordance with this regulation, carry out or have carried out
the necessary noise tests.
4. If the equipment meets the provisions of this
Regulation, the notified body shall issue a certificate of
conformity to the applicant as described in
Annex X of the noise directive.
If the notified body refuses to issue a certificate of
compliance, the Agency detailed reasons for its refusal.
5. the manufacturer or his representative shall, at least ten years after
the date on which the equipment is placed on the market preserve
copies of the certificate of conformity with the
technical documentation. Regulation (2010:1334).
Annex 5
Full quality assurance
1. This annex describes the procedure whereby the
the manufacturer who fulfils the obligations laid down in paragraph 2
ensures and declares that the equipment concerned
comply with the requirements of this regulation. The manufacturer or
the manufacturer's authorised representative established within the European Union must affix the
The CE marking, accompanied by the information set out in section 8
This regulation to each product and draw up a
written declaration of conformity in accordance with article 7 of
This regulation.
2. The manufacturer shall operate an approved
quality assurance system for design, manufacture,
final product inspection and testing as specified
in point 3 and shall be monitored in accordance with paragraph 4.
3. Quality assurance system
3.1. the manufacturer shall lodge an application for assessment of
his quality assurance system with a notified
bodies.
The application must include:
a) all relevant information for the current
product category, including technical documentation of all
equipment that is already in the design or
the manufacturing stage, with at least the following information:
– the name and address of the manufacturer or the manufacturer's within
representative established within the European Union,
– a description of the equipment,
-the make,
-trade names,
– type, serial and serial number,
– the technical data relevant for the identification of
the equipment and the assessment of the noise the
accomplishes, including, where appropriate, schematic
drawings and descriptions and explanations
is necessary to understand these,
– a reference to the noise directive,
– the technical report of noise measurements carried out
in accordance with the provisions of this regulation,
-the technical instruments applied and the results of
the evaluation of the uncertainties due
variation in the manufacturing process and their connection with the
guaranteed sound power level, and
– a copy of the Declaration of conformity, and
(b)) the documentation concerning the quality system.
3.2. The quality system shall ensure that
its conformity with the relevant requirements of
European Union legislation and the corresponding national
the legislation.
All the elements, requirements and provisions adopted by the
the manufacturer shall be documented in a systematic and
orderly in the form of written policies, procedures
and instructions. This documentation of
the quality system shall ensure a common
interpretation of the guidelines and procedures for the quality,
such as quality programmes, plans, manuals and
document.
3.3 documentation must include in particular an adequate
description of
-the quality objectives and the organisational structure, management's
responsibilities and powers of the management with regard to design and
product quality,
– the technical documentation to be drawn up for each
product, covering at least the information set out in
point 3.1 for the technical documentations mentioned there
– the techniques, processes and systematic actions
design control and design verification
will be used when designing the products in
the product category covered,
– the corresponding techniques, processes and systematic
procedures for manufacturing, quality control and
quality assurance that will be used;
-the examinations and tests that will be
be carried out before, during and after manufacture, and how
often they will be implemented,
– the quality records, such as inspection reports,
test data, calibration data, reports concerning the
qualifications of the personnel concerned, etc.,
– the means of monitoring the target design
and product quality and the
the quality system is working effectively.
The notified body shall assess the quality assurance system
in order to determine whether it meets the requirements referred to in
3.2. Body shall presume that
the quality assurance system that complies with EN ISO 9001, or
corresponding national standard, compatible with the requirements.
The auditing team shall have at least one member with experience of evaluation
in the product technology concerned. The assessment procedure
shall include an assessment visit to the manufacturer's premises.
The manufacturer must be notified of the decision. The message to be
contain the conclusions of the examination and the
reasoned assessment decision.
3.4. the manufacturer shall undertake to fulfil the obligations
arising out of the approved quality assurance system
and ensure that it remains adequate and
effectively.
The manufacturer or the manufacturer's established within the Union
representative shall inform the notified body which approved the
the quality assurance system informed of any intended updating of the
the system.
The notified body shall evaluate the proposed
changes and decide whether the modified
the quality assurance system will still satisfy the requirements
referred to in point 3.2 or whether a reassessment is
necessary.
The notified body shall issue its decision. The message
shall contain the conclusions of the examination and the
reasoned assessment decision.
4. surveillance under the responsibility of the notified body
4.1. the purpose of surveillance is to ensure that
the manufacturer duly fulfils the obligations
arising out of the approved quality assurance system.
4.2. the manufacturer shall allow the notified body control
access to the design, manufacture,
inspection, testing and storage and shall provide it with all
necessary information, in particular:
– the documentation concerning the quality system,
– the quality records as foreseen by the quality assurance system
structural component, such as results of analyses,
calculations, tests, etc.,
– the quality records as foreseen by the quality assurance system
the manufacturing component, such as inspection reports,
test data, calibration data, reports concerning the
qualifications of the personnel concerned, etc.
4.3. the notified body shall periodically carry out
audits to make sure that the manufacturer
maintains and applies the quality system and shall provide an
audit report to the manufacturer.
4.4. Additionally, the notified body may make unannounced visits
with the manufacturer. During such visits, body may, if necessary,
perform or have performed the tests in order to check
the quality system is functioning correctly. Body
shall provide the manufacturer with a visit report and, if a test has
been carried out, with a test report.
5. The manufacturer must, for at least 10 years after the
manufacture of equipment has been manufactured, keep at the disposal
of the national authorities:
— the documentation referred to in point 3.1, second
Indent,
-the change referred to in point 3.4, second subparagraph, the
decisions and reports from the notified body which are referred to in
the final subparagraph of point 3.4, and in sections 4.3 and 4.4.
6. Each notified body must give the other notified bodies
the relevant information concerning the revocation
the quality system approvals.
Regulation (2010:1334).
Annex 6
Internal production control
1. this annex describes the procedure to be followed
by the manufacturer or the manufacturer's in the Union
authorised representative who fulfils the obligations laid down in paragraph 2, for
that ensures and declares that the equipment concerned
comply with the requirements of this regulation. The manufacturer or
the delegate shall according to section 8 of this regulation on all equipment
affix the CE marking of conformity and the indication
of the guaranteed sound power level and the setting up of a
written declaration of conformity under section 7.
2. the manufacturer or his representative shall draw up the technical
documentation described in section 3 and for at least ten
years after the last product
manufacturing date keep this available for interested
national authorities for inspection purposes. Manufacturer
or the Registrar may assign the responsibility to preserve the
technical documentation to another person. In this case,
manufacturer or agent must include the person's name
and address in their EU-Declaration of conformity.
3. The technical documentation shall enable a
assessment of whether the equipment complies with the
the requirements of this regulation. It should contain at least
the following information:
– the name and address of the manufacturer or the manufacturer's within
representative established within the European Union,
– a description of the equipment,
-the make,
-trade names,
– type, serial and serial number,
– the technical data relevant for the identification of
the equipment and the assessment of the noise the
accomplishes, including, where appropriate, schematic
drawings and descriptions and explanations
is necessary to understand these,
– a reference to the noise directive,
– the technical report of noise measurements carried out
in accordance with the provisions of this regulation, and
-the technical instruments applied and the results of
the evaluation of the uncertainties due
variation in the manufacturing process and their connection with the
guaranteed sound power level.
4. The manufacturer shall take all measures necessary for
the manufacturing process shall ensure that the
manufactured equipment will continue to comply with
the technical documentation referred to in paragraphs 2 and 3
and with the requirements of this regulation. Regulation (2010:1334).
